Legal & Regulatory

The FDA selected seven companies, including two CGT manufacturers, for its PreCheck Pilot to accelerate domestic manufacturing approvals and bolster supply chain resilience.

A US Section 301 probe into Germany's drug pricing could bring tariffs on APIs and finished drugs, raising new supply chain and pricing risks.

CMS' proposed framework for 2029 and beyond closes a potential formulation loophole and raises the stakes for launch planning.

A new CMS demonstration launching July 1 will offer eligible Part D beneficiaries access to branded obesity drugs at a $50 copay. Here's what manufacturers, payers, and pharmacies need to know.

Erez Israeli explains how Dr. Reddy's approached commercial readiness for its generic semaglutide launch in Canada and what vertical integration in peptide manufacturing means for the GLP-1 market.

FDA approves Shionogi's Xocova, the first oral post-exposure COVID-19 prevention therapy, reducing infection risk by 67% in Phase III trials.

The Supreme Court declined pharma appeals, letting Medicare drug price negotiations under the IRA proceed, solidifying federal pricing authority.

US pharma supply chains are shifting amid regulation and geopolitics, with BIOSECURE driving less Asia reliance and more complex, distributed networks.

FDA commissioner Marty Makary is planning to resign today, according to sources close to the White House.

According to the Wall Street Journal, a source close to the White House said FDA commissioner Marty Makary "is done."

For drugs already on the market, there may be little companies can do to limit business impact; however, for new development drugs, there are some critical considerations.

In this week's Pharma Pulse, Eli Lilly opens its new genetic medicine plant, Bayer acquires Perfuse Therapeutics, and more.

In this week’s Pharma Pulse, the launch of the Ember Cube 2, exclusive policy insights from Asembia AXS26, a record-breaking prescription spending outlook for 2026 and more.

At Asembia AXS26, Dee Chaudhary broke down how shifting US drug pricing policy is tightening payer controls and changing pharmaceutical pricing and forecasting.

Pharma importers can apply for tariff reimbursements through the US Customs and Border Protection’s online portal.

President Trump signed an executive order to fast-track FDA review of psychedelic therapies for mental health conditions.

Charley Maxwell explains why Annex 21 is not just a regulatory hurdle, but a key commercial risk point.

Mastering the PSMF is critical for inspection readiness, as it provides regulators an early look at your pharmacovigilance system's compliance.

Post-approval changes are overwhelming pharma ops teams. Here's why lifecycle change management has become one of the industry's most consequential and overlooked operational risks.

Pharma companies could face 100% tariffs under new US rules, with relief available for those prioritizing onshore manufacturing or pricing concessions.

Eli Lilly’s newest GLP-1, Foundayo (orforglipron), is the first FDA-approved weight loss pill that can be taken without food or water restrictions.

In today’s Pharma Pulse, Eli Lilly calls for the U.K. government to overhaul its drug pricing framework and the FDA approves Ponlimsi.

In today’s Pharma Pulse, experts warn of zero-prefix collision risks in the NDC-12 transition, and the FDA grants accelerated approval to Avlayah for Hunter syndrome.

How the zero-prefix collision will disrupt reimbursement, patient access, brand protection and market intelligence — and what commercial leaders must do before 2033.

In today's Pharma Pulse, the FDA flags misleading promotional claims from ImmunityBio regarding its cancer therapy and MedImpact launches new solutions to address the skyrocketing employer costs of GLP-1 weight management therapies.